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news.Calypte Biomedical has announced that the Chinese State Food and Drug Administration has notified Calypte's Chinese manufacturing subsidiary, Beijing Marr Bio-pharmaceutical that the technical review of its Aware HIV-1/2 OMT rapid oral test product application has been completed.
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Pending the SFDA’s review of conformity to product standard documents and labeling to applicable regulations, the application will progress to the concluding administrative approval. The Aware HIV-1/2 OMT product is a rapid test using oral fluid to diagnose HIV-1 or HIV-2 infection in as little as 20 minutes with an accuracy comparable to that of FDA approved blood based laboratory HIV EIA tests.
David Harris, CEO of Beijing Marr, said: “The notice from the SFDA is of paramount importance and indicates that the substantive content of the application and the technology itself have met with the acceptance of the SFDA and are acceptable for the Chinese market.”